Toprion Bio conducts Phase I and Phase II clinical trials. Our clinical R&D team participates in the design of clinical trial protocols for new drugs during the preclinical animal study stage, enabling simpler, more efficient and comprehensive management of complex clinical trials. We help clients bring products to market as early as possible to meet […]
Toprion Bio undertakes Phase I and Phase II clinical trials. From Phase I clinical studies to final registration and submission, we help innovative and breakthrough pharmaceutical products launch to the market as soon as possible and benefit patients through our strict quality control system and the extensive experience of our professional team. Clinical Registration and
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PK/PD studies utilize analytical methods to determine the distribution levels of test compounds and biomarkers in the circulatory system and various tissues, especially target organs, in normal or disease model animals, thereby establishing the correlation between drug metabolism and pharmacological response. In vivo PK and PD studies enable our clients to balance efficacy and potential
Toprion Bio provides clients with in vivo pharmacokinetic and toxicokinetic data of pharmaceuticals, as well as formulation development and screening for vehicles during drug discovery and preclinical stages. Test compounds include small-molecule drugs, peptides, nucleosides and nucleotides, cell therapy products, gene therapy products, and various biological macromolecules. Experimental animals cover a wide range of species,
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In vitro studies include metabolic stability, P450 induction and inhibition, metabolic pathway identification, metabolite characterization, and other research items, involving animals such as rats, mice, rabbits, dogs, monkeys, etc. Toprion Bio provides comprehensive in vitro ADME, in vitro toxicity, and in vivo pharmacokinetic (PK) services. We offer a full package of ADME and pharmacokinetic evaluation
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Biomarker research plays a crucial role in drug discovery, particularly in target identification and candidate drug screening. Biomarker analysis forms an essential part of mechanistic investigation, efficacy evaluation, bioavailability assessment, and safety considerations. The accuracy and sensitivity of measurements are critical when determining whether a study can proceed. Leveraging advanced analytical technologies, Toprion Bio provides
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Provide pathological evaluation services in compliance with multiple GLP requirements including those of the U.S. FDA, the Organisation for Economic Co-operation and Development (OECD), and China’s NMPA (formerly CFDA). Comprehensive interpretation of pathological data and integrated pathology reports are provided by board-certified veterinary pathologists licensed in the United States and in-house veterinary pathologists licensed in
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Test Capabilities Animal Species Rodents Non-Rodents Toprion Bio provides clients with safety evaluation services including general toxicology, safety pharmacology, reproductive and developmental toxicity, genetic toxicology, immunotoxicology, as well as pharmacokinetics and toxicokinetics, covering the entire process from drug discovery to IND and NDA submissions. Through cost-effective and efficient services, we help clients shorten experimental duration
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Toprion Bio provides immunology services to support the preclinical development of immunotoxicity assessment and immunogenicity analysis. Through the analysis of preclinical and clinical samples, method development and validation, as well as immunogenicity and immunotoxicity studies, we support our clients’ drug development needs. The immune system is a highly specific and challenging drug target. Our technology
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Toprion Bio’s Analytical and Bioanalytical Department boasts a highly skilled and experienced analytical team, capable of developing, validating and applying a wide range of analytical methods to provide clients with comprehensive, high‑quality testing and analytical services. As a critical platform, the Analytical and Bioanalytical Department plays an essential role in supporting the systematic development of
